Functional Health Services for Your Well Being

More Justifaction of Statins

by Alex Boersma

JUPITER: Best CVD event reduction in patients with very low LDL-cholesterol levels

Heartwire – April 15, 2011

The JUPITER study:  Justification for the Use of Statins in Primary Prevention.  The name says it all.  This study was designed to justify the use of statins for people who do not have heart disease.  In other words:

We think lots of people should take statins, regardless of whether or not they have heart disease.  Let’s design a study which will justify millions of new clients for our expensive new drug!

jupiter

JUPITER – HOME OF THE ASTRAZENECANS

Purveyors of pharmaceutical grade justification 

“We”, of course, refers to AstraZeneca, the pharmaceutical company which owns the patented rights to Rosuvastatin, the drug being tested in the JUPITER study.  Also, the company which stood to make billions of dollars in statin sales if JUPITER could prove that people with normal levels of cholesterol should start popping statins with their breakfast cereal.  Also, the company which cut the trial short after less than 2 years just as diabetes was beginning to emerge as a significant side effect of taking Rosuvastatin!

Kudos to the AstroZenecan drug pushers.  They sure know how to set themselves up for success.

Here’s the thing.  We know that atherosclerosis is an inflammatory disease.  We know that if the walls of our arteries are inflamed, they will incorporate small, dense, oxidized LDL particles into plaques faster than a government sanctioned drug pusher can say “Crestor”.  So if we want to reduce our risk of heart disease, we can:

  • Reduce the inflammation in the walls of our arteries
  • Reduce the number of small, dense, oxidized Ldl particles in our arteries
  • Or, even better, we can do both

That’s exactly what the AstraZenecans did.  They found 17,000 middle aged/elderly people who had dangerously high levels of a blood marker of inflammation called CRP but normal LDL levels. (No easy task, since only 1 in 5 people with high CRP have normal LDL levels).  Next, they randomly separated these people into 2 groups, one of which received 20mg/day of Rosuvastatin, the other of which got a placebo.  After 2 years, the people taking statins had reduced their CRP (inflammation) by about 1/3 and their LDL by about 1/2 (they didn’t measure small dense LDL particles, but let’s give them the benefit of the doubt and assume these made up a significant percentage of the loss in LDL).  The chance of having a major cardiovascular event in the statin group over those 2 years was just under 1 in 100 (.77%).  In the placebo group, the chance of having a major cardiovascular event was just over 1 in 100 (1.36%).  The chance of being dead at the end of the 2 years – in case you’re interested – was 1% in the statin group and 1.25% in the placebo group.

Looks pretty good so far, doesn’t it?

Having your risk of heart attack over a 2 year time period reduced from just over 1 in 100 to just under1 in 100 isn’t exactly going to get you pleading with your doctor for a daily dose of statins.  The AstroZenecans obviously realized this, so they decided to publish the results as a percentage of risk reduction instead of the actual risk reduction.  If you look at the numbers from this perspective, you get to say that “Crestor decreases your risk of having a heart attack by 47%!”  Now that’s a bit more compelling of a headline!

For a little perspective on this chicanery, your favourite lottery could begin offering two 1 million dollar prizes instead of one.  It could then advertise that it had increased the chances of winning by 100%. A  headline like that might create lineups at your local lottery and gaming  kiosk, but not so much if they also explained that the chances of winning the jackpot had merely increased from 1 in 10 million to 2 in 10 million.  But they wouldn’t do that, would they?

Of course they wouldn’t.  That wouldn’t be very good for business. 

Nobody will ever accuse the AstroZenecans of doing things that aren’t good for business.  And explaining to prospective consumers exactly what a “47% reduction in risk of having a heart attack” means is decidedly bad for business.  Nothing new here.  Consumer beware!

 

But here’s what gets my goat:

get my goat

6 years after the JUPITER study was brought to an untimely end, it remains the single most referenced study exploiting the necessity of plying perfectly healthy people with perfectly unnecessary cholesterol lowering drugs.  6 years later, we get this article from Heartwire, which delivers heart related “research” online to an audience composed primarily of medical professionals.  Here is the first paragraph from that article:

A new analysis from Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) suggests even greater reductions in the risk of major cardiovascular events among individuals who achieve very low levels of LDL cholesterol.”

YEAH – IN PEOPLE WITH SKYROCKETING LEVELS OF INFLAMMATION!!!

heart-on-fire

Oops, they forgot to mention that part!

In fact, if you read the article here, you might find it interesting to count the number of times LDL is mentioned compared to the number of times CRP is mentioned.  I see LDL on almost every line…24 times, in total.   CRP?  Not so much…only 4 times if I’m counting right.

JUPITER was about giving a powerful anti-inflammatory drug (Rosuvastatin) to people with extra-ordinarily high levels of inflammation who had normal cholesterol levels.  Can we really go on to say that it “JUSTIFIES” lowering LDL to below 50 in anybody else?

 

So your very busy doctor takes a few minutes to check his email and comes across the heartwire article saying the lower your LDL is, the better.  More than likely he already believes firmly in the value of LDL as a predictive tool for measuring the risk of heart disease.  This little headline just adds to his confirmation bias.  If he takes the time to read the article, he gets to hear from a bunch of “experts” who endorse the conclusion that optimal LDL levels should be  around 50 (that’s about 1.5 mmol/l in Canada) and that taking Rosuvastatin is the best way to get them there. 

But here’s the multi-billion dollar question:

T890/0494

Will your busy doctor get the entire message?  Will he prescribe a CRP test for you to establish your level of inflammation?  If so, the AstraZenecans stand to make a handsome profit anyway since they conveniently patented the CRP test.  Or will he just get the part of the message which implies that everybody with LDL over 1.5mmol/l would benefit from a statin and could we please, please, please just start dumping Crestor in the water supply?

If Crestor and other statins like it were as effective as their inventors said they were, they wouldn’t need justification.  But the truth is, in most populations, there is very little solid evidence to prove their usefulness.  Sure, if you’ve already had a heart attack, they may help.  And I guess, if you have high CRP levels, you might be convinced that taking an expensive drug with arguably serious side effects is worth the less than 1 in 100 improvement in risk.  You could, of course, simply initiate a few dietary and lifestyle changes to bring your CRP levels down, but that wouldn’t help out the AstraZenecans very much would it?

BOTTOM LINE

Jupiter is a very controversial studyThe AstraZenecans don’t publicize anything about the peer reviewed critiques which question the validity of any conclusions based on JUPITER.  It is only one piece in a multi-faceted puzzle of research all confounded by well documented publication bias.  When we look at this research as a whole, the conclusions regarding use of statins in the primary prevention of heart disease (primary means those who have not been diagnosed with heart disease but may be deemed at risk for it) are by no means compelling.  A 2006 study by University of Toronto researchers looking at the evidence as a whole came up with this conclusion:

“In patients without CV disease, statin therapy decreases the incidence of major coronary and cerebrovascular events and revascularizations but not coronary heart disease or overall mortality.”

Translation:  If you take statins despite not having heart disease, you won’t have as many heart attacks, but you won’t live any longer or be any healthier.

Another meta-analysis published in the Arch Intern Med 2010 Jun 28;170(12):1024-31. came up with an even more definative conclusion:
 

“This literature-based meta-analysis did not find evidence for the benefit of statin therapy on all-cause mortality in a high-risk primary prevention set-up.”

Translation:  Even if you are at high risk for heart disease, statins won’t help you live any longer.

 

Are we all really better off with extremely low levels of LDL?  Is Rosuvastatin really the best thing we can do for our health?

Only if you ask the AstraZenecans!

 

 

 

 

 

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